Midline Catheters Versus Peripheral Catheters in Internal Medicine Unit

Vascular Access Complication Clinical Trial

Official title:

Análisis de la utilización de Los catéteres Intravenosos periféricos de Linea Media Frente a Los catéteres Intravenosos periféricos Convencionales en el Servicio de Medicina Interna

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05512117
• Other study ID #: HGUValencia_midline
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: September 30, 2017

Study information

• Verified date: August 2022
• Source: Hospital General Universitario de Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study aims to evaluate the rate of complications and the duration of cannulation of a midline intravenous catheter compared to a short peripheral catheter in patients hospitalized in an Internal Medicine service of a Spanish hospital.

Description:

A randomized, longitudinal experimental study is designed, which will allow comparisons to be made between the results obtained in the experimental group and the control group.

The study will be carried out in the Internal Medicine and medium and long stay unit of the CHGUV, during the period of time necessary to complete the required sample size, which has finally been established at six months.

When the patient is admitted to our unit, a number is assigned from the admission service, based on their admission order; this number will serve for subsequent random assignment to one another group. In this case, the use of a website to generate said numbers is proposed.

Using established procedures for the generation of random numbers, the numbers that correspond to the subjects that are going to be part of each of the groups will be identified.

The list of random numbers that will make up the experimental group has been prepared previously by the Internal Medicine Unit secretary and will be known by the person who will carry out the placement of the midline catheter (two nurses from the unit trained in the placement and handling of this type of device, who will also be those in charge of training the rest of the staff).

The list will be reviewed daily in the morning shift, and those patients who have not given their informed consent will be eliminated, those in whom, due to their pathology, a brief admission is expected or patients who are in a terminal or palliative care situation, in those who consider the step of treatment to the subcutaneous route as the best option.

The informed consent to participate in the study will be given to the patient and/or relatives at the time of admission, also informing them that the next morning those responsible for the study will explain the object of the study in more depth and answer their questions.

Before the third day after admission, in the morning shift, the peripheral catheters will be reviewed and replaced by another peripheral catheter or by a midline catheter depending on the group to which the patient has been assigned. In case of being a patient assigned to the experimental group, the midline catheter will be placed by personnel trained for it.

The procedures for inserting and maintaining the catheters are already established in the unit and will be those that will be followed during the study, depending on the type of catheter; The care in the insertion and maintenance of midline catheters does not differ from the care of peripherally inserted central catheters, since they require a sterile technique; therefore, although the insertion of the midline catheters will be done by the selected investigators, maintenance will be performed by the unit's staff, following, as we have indicated, the procedures already established.

When the patient requires a change of venous access for whatever reason, it will be replaced by the same type of catheter (midline or conventional catheter) and the necessary information will be added to the information record sheet.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 30, 2017
• Est. primary completion date: April 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• The patients included were those who were hospitalized in the Internal Medicine Service of the Consorcio Hospital General Universitario de Valencia who needed intravenous therapy and who had signed the Informed Consent for placement of a midline at the time of the change of the PIVC placed in the emergency unit.

Exclusion Criteria:

• Those with a forecast hospitalization of less than one week, those who were receiving palliative or symptomatic treatment, those who were carriers of a CVC or those who had presented difficulty in venous access with midline after two consecutive attempts were excluded

Related Conditions & MeSH terms

• Vascular Access Complication
• Vascular Access Device Complications

Intervention

Device:
• Midline insertion
Midline catheter insertion

Locations

Country	Name	City	State
Spain	Hospital General Universitario de Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Universitario de Valencia

Country where clinical trial is conducted

Spain, 

References & Publications (12)

Farina J, Cornistein W, Balasini C, Chuluyan J, Blanco M. [Central venous catheter related infections. Inter-Societies update and recommendations]. Medicina (B Aires). 2019;79(1):53-60. Spanish. — View Citation

Johansen H, Helgesen AK. Palliative care in the community - the role of the resource nurse, a qualitative study. BMC Palliat Care. 2021 Oct 14;20(1):157. doi: 10.1186/s12904-021-00860-w. — View Citation

Millington SJ, Hendin A, Shiloh AL, Koenig S. Better With Ultrasound: Peripheral Intravenous Catheter Insertion. Chest. 2020 Feb;157(2):369-375. doi: 10.1016/j.chest.2019.04.139. Epub 2019 Oct 22. Review. — View Citation

Mohn-Brown E. Implementing Quality and Safety Education for Nurses in Postclinical Conferences: Transforming the Design of Clinical Nursing Education. Nurse Educ. 2017 Sep/Oct;42(5S Suppl 1):S18-S21. doi: 10.1097/NNE.0000000000000410. — View Citation

Moureau N, Chopra V. Indications for peripheral, midline and central catheters: summary of the MAGIC recommendations. Br J Nurs. 2016 Apr 28-May 11;25(8):S15-24. doi: 10.12968/bjon.2016.25.8.S15. — View Citation

Nickel B. Does the Midline Peripheral Intravenous Catheter Have a Place in Critical Care? Crit Care Nurse. 2021 Dec 1;41(6):e1-e21. doi: 10.4037/ccn2021818. — View Citation

Panepinto R, Harris J, Wellette J. A Review of Best Practices Related to Intravenous Line Management for Nurses. Nurs Clin North Am. 2021 Sep;56(3):389-399. doi: 10.1016/j.cnur.2021.05.001. Review. — View Citation

Prasanna N, Yamane D, Haridasa N, Davison D, Sparks A, Hawkins K. Safety and efficacy of vasopressor administration through midline catheters. J Crit Care. 2021 Feb;61:1-4. doi: 10.1016/j.jcrc.2020.09.024. Epub 2020 Oct 2. — View Citation

Scoppettuolo G, Pittiruti M, Pitoni S, Dolcetti L, Emoli A, Mitidieri A, Migliorini I, Annetta MG. Ultrasound-guided "short" midline catheters for difficult venous access in the emergency department: a retrospective analysis. Int J Emerg Med. 2016 Dec;9(1):3. doi: 10.1186/s12245-016-0100-0. Epub 2016 Feb 4. — View Citation

Selby LM, Rupp ME, Cawcutt KA. Prevention of Central-Line Associated Bloodstream Infections: 2021 Update. Infect Dis Clin North Am. 2021 Dec;35(4):841-856. doi: 10.1016/j.idc.2021.07.004. Review. — View Citation

Skaggs MKD, Daniels JF, Hodge AJ, DeCamp VL. Using the Evidence-Based Practice Service Nursing Bundle to Increase Patient Satisfaction. J Emerg Nurs. 2018 Jan;44(1):37-45. doi: 10.1016/j.jen.2017.10.011. Epub 2017 Nov 20. — View Citation

Timsit JF, Baleine J, Bernard L, Calvino-Gunther S, Darmon M, Dellamonica J, Desruennes E, Leone M, Lepape A, Leroy O, Lucet JC, Merchaoui Z, Mimoz O, Misset B, Parienti JJ, Quenot JP, Roch A, Schmidt M, Slama M, Souweine B, Zahar JR, Zingg W, Bodet-Contentin L, Maxime V. Expert consensus-based clinical practice guidelines management of intravascular catheters in the intensive care unit. Ann Intensive Care. 2020 Sep 7;10(1):118. doi: 10.1186/s13613-020-00713-4. Review. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of canalization	Days of catheter stay	Four weeks
Primary	Number of punctures	Number of times a catheter is inserted	Four weeks
Primary	Phlebitis	Presence of catheter related phlebitis	Four weeks